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Biosimilars Marching Forward as Planned

Marie A. Vodicka

Marie A. Vodicka,

Washington, D.C.

David M. Fox

David M. Fox,

Washington, D.C.

29 June 2012
With the 5-4 decision from the U. S. Supreme Court upholding almost the entire Patient Protection and Affordable Care Act, for those who were hoping for a fresh opportunity to re-debate the biosimilars statute, and perhaps plug some holes or make some basic changes to the law, those hopes have been dashed for now.

While the merits of the Biologics and Price Competition Act were not in play during the Supreme Court’s evaluation of the constitutionality of PPACA, few changes to the approval and regulations of medicines in this country have had the potential for such a large effect on what medicines will be available to patients.  Prior to enactment, there was no abbreviated pathway for approval of biologic medicines under the Public Health Service Act. BPCIA, buried within PPACA, created that pathway in the U.S.

With Thursday’s (June 28, 2012) Supreme Court decision, any remaining legal debris has been cleared from the path and it looks like biosimilars in the U.S. will march ahead.

Marie A. Vodicka

Marie A. Vodicka,

Washington, D.C.

David M. Fox

David M. Fox,

Washington, D.C.

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